FDA recall Z-1103-2023

Product

SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)

Reason for recall

A grainy image is observed when using a SPiN Vision Single-Use Flexible Bronchoscope (models INS-7100 or INS-7130) with the SYS-4000 system due to an incorrect DVI cable supplied may result in prolonged procedure/surgery due to additional time to troubleshoot the device

Distribution

FL, GA, IN, MD, MS, NY, OH, PA, RI, SC, VA

Key facts

Status

Ongoing

Initiation date

2022-12-13

Report date

2023-02-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1103-2023